Clinical ReasoningNCT04241445
Tracking General Movements
An observational study of Clinical Reasoning and Cerebral Palsy, run by Medical University of Graz at 1 site in Austria.
Trial summary
Background: General movements (GMs) are endogenously generated movements of the entire body observable from the 9th week postmenstrual age to at least 20 weeks postterm age. The assessment of GMs, the GMA, is a method to differentiate between spontaneous normal vs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Reasoning, Cerebral Palsy, General Movement Assessment
- How many people
- 140 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2020to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For the proposed experiments, observers will be divided into three groups. One group will consist of (a) naïve observers, that is, individuals who are not familiar with GMs, have not received any GMA training and are not medically educated. The two other groups will consist of (b) GMA-trained and certified observers: (b1) novice observers who have practiced GMA sporadically (def.: <= 2 GMA/week for <= 2 years) and have only little experience; and (b2) GMA experts, i.e. GMA tutors and individuals who have applied GMA regularly (def.: > 2 GMA/week for > 2 years).
Who may be able to join
- Observers have to provide written informed consent to the study protocol, data analysis and data storage guidelines, as well as the publication of study results.
- Observers have to complete the experimental data acquisition. Apart from their lack of GMA training, naïve observers have to be of the same gender, of comparable age and educational level as GMA-trained observers.
- Novice observers and GMA experts have to be certified for GMA. Observers must have normal or corrected-to-normal vision (only individuals wearing soft contact lenses can be included in the eye tracking experiments).
Who cannot join
- Observers did not adhere to the study protocol, data analysis, data storage guidelines, or the publication of study results.
- Observers did not complete the experimental data acquisition. Observers have uncorrected visual impairments or visual impairments corrected with glasses/hard contact lenses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tracking General Movements: An Observing-the-Observer Approach to Enhance Clinical Reasoning
Background: General movements (GMs) are endogenously generated movements of the entire body observable from the 9th week postmenstrual age to at least 20 weeks postterm age. The assessment of GMs, the GMA, is a method to differentiate between spontaneous normal vs. abnormal motor patterns based on visual Gestalt perception, and has proven to be a reliable tool to evaluate the integrity of the nervous system in early infancy. Trained GMA observers achieve an excellent inter-observer agreement, but this accuracy is known to decline when GMA is applied infrequently. Although specific changes in the quality of GMs are highly predictive for atypical neurodevelopmental trajectories, one pattern of GMs, the poor-repertoire, is still of low predictive power.
Objectives: Tracking GMA observers' intrinsic and unconsciously applied analytic strategies may unravel hitherto unknown characteristics of GMs and Gestalt perception in clinical reasoning. We specifically aim to: detect parameters during the writhing movements period which differentiate normalising and deteriorating developmental trajectories (Aim 1); evaluate different strategies/modalities of expert guidance for clinical reasoning and develop novel didactical approaches for remote GMA training (remote visual and verbal guidance; Aim 2); create a database to provide expert-guided tutorials for remote clinical training, observer re-calibration, and self-evaluation for certified observers (Aim 3).
Read the detailed description
Approach / methods: Based on our expertise in GMA and eye tracking, and a successful proof of principle (pilot experiment), we will conduct a series of experiments: GMA experts' eye movement patterns during clinical reasoning will be assessed to better understand the diagnostic category of poor-repertoire GMs (Experiment 1); benefits and potential difficulties of different modes of "seeing through the eyes of an expert"-approaches for GMA-training will be explored (Experiment 2); we shall evaluate enhancement of clinical reasoning as a result of intensive remote GMA training (Experiment 3).
Level of originality / innovation: "Tracking general movements" will (1) contribute to better understand poor-repertoire GMs adding to the clinical necessity to closely follow infants in need for continuous or close-meshed clinical surveillance; (2) define the benefits of different modes/modalities of expert guidance for GMA, which will form the basis for innovative remote clinical GMA training; and (3) create a globally accessible database for remote clinical GMA refreshment-training and re-calibration.
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| novice observers | who have practiced GMA sporadically (def.: < = 2 GMA/week for < = 2 years), have limited experience, and do not use GMA in clinical settings | |
| GMA experts | GMA tutors and individuals who have applied GMA regularly (def.: > 2 GMA/week for > 2 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spotlight on the very early motor repertoire: writhing general movements (WMs); GMA experts only
Detect parameters during the WMs period which differentiate normalising and deteriorating GM traits by experts
Measured: 1st - 16th month
Expert-guided clinical reasoning - "seeing through the eyes of an expert"
Develop and provide expert-guided video recordings to complement GMA trainings with three modes of visual expert guidance (i: verbal; ii: visual; iii: verbal+visual) to enhance clinical reasoning in novice observers
Measured: 21st - 32rd month
Implementation of a database and intensive remote GMA training
Create the prototype of a password-protected database for clinical GMA training. The database will cover three distinct aspects of GMA training: (i) expert-guided remote training, (ii) re-calibration, and (iii) self-evaluation
Measured: 17th - 48th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical ReasoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241445
- Sponsor's protocol ID
- 30-261 ex 17/18
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking General Movements: An Observing-the-Observer Approach to Enhance Clinical Reasoning
- ClinicalTrials.gov ID
- NCT04241445
- Acronym / sponsor ID
- 30-261 ex 17/18
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: General movements (GMs) are endogenously generated movements of the entire body observable from the 9th week postmenstrual age to at least 20 weeks postterm age. The assessment of GMs, the GMA, is a method to differentiate between spontaneous normal vs. abnormal motor patterns based on visual Gestalt perception, and has proven to be a reliable tool to evaluate the integrity of the nervous system in early infancy. Trained GMA observers achieve an excellent inter-observer agreement, but this accuracy is known to decline when GMA is applied infrequently. Although specific changes in the quality of GMs are highly predictive for atypical neurodevelopmental trajectories, one pattern of GMs, the poor-repertoire, is still of low predictive power.
Objectives: Tracking GMA observers' intrinsic and unconsciously applied analytic strategies may unravel hitherto unknown characteristics of GMs and Gestalt perception in clinical reasoning. We specifically aim to: detect parameters during the writhing movements period which differentiate normalising and deteriorating developmental trajectories (Aim 1); evaluate different strategies/modalities of expert guidance for clinical reasoning and develop novel didactical approaches for remote GMA training (remote visual and verbal guidance; Aim 2); create a database to provide expert-guided tutorials for remote clinical training, observer re-calibration, and self-evaluation for certified observers (Aim 3).
Detailed description
Approach / methods: Based on our expertise in GMA and eye tracking, and a successful proof of principle (pilot experiment), we will conduct a series of experiments: GMA experts' eye movement patterns during clinical reasoning will be assessed to better understand the diagnostic category of poor-repertoire GMs (Experiment 1); benefits and potential difficulties of different modes of "seeing through the eyes of an expert"-approaches for GMA-training will be explored (Experiment 2); we shall evaluate enhancement of clinical reasoning as a result of intensive remote GMA training (Experiment 3).
Level of originality / innovation: "Tracking general movements" will (1) contribute to better understand poor-repertoire GMs adding to the clinical necessity to closely follow infants in need for continuous or close-meshed clinical surveillance; (2) define the benefits of different modes/modalities of expert guidance for GMA, which will form the basis for innovative remote clinical GMA training; and (3) create a globally accessible database for remote clinical GMA refreshment-training and re-calibration.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| novice observers | – | –who have practiced GMA sporadically (def.: < = 2 GMA/week for < = 2 years), have limited experience, and do not use GMA in clinical settings |
| GMA experts | – | –GMA tutors and individuals who have applied GMA regularly (def.: > 2 GMA/week for > 2 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For the proposed experiments, observers will be divided into three groups. One group will consist of (a) naïve observers, that is, individuals who are not familiar with GMs, have not received any GMA training and are not medically educated. The two other groups will consist of (b) GMA-trained and certified observers: (b1) novice observers who have practiced GMA sporadically (def.: <= 2 GMA/week for <= 2 years) and have only little experience; and (b2) GMA experts, i.e. GMA tutors and individuals who have applied GMA regularly (def.: > 2 GMA/week for > 2 years).
Key inclusion criteria (3 listed)
- Observers have to provide written informed consent to the study protocol, data analysis and data storage guidelines, as well as the publication of study results.
- Observers have to complete the experimental data acquisition. Apart from their lack of GMA training, naïve observers have to be of the same gender, of comparable age and educational level as GMA-trained observers.
- Novice observers and GMA experts have to be certified for GMA. Observers must have normal or corrected-to-normal vision (only individuals wearing soft contact lenses can be included in the eye tracking experiments).
Key exclusion criteria (2 listed)
- Observers did not adhere to the study protocol, data analysis, data storage guidelines, or the publication of study results.
- Observers did not complete the experimental data acquisition. Observers have uncorrected visual impairments or visual impairments corrected with glasses/hard contact lenses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spotlight on the very early motor repertoire: writhing general movements (WMs); GMA experts only
Time frame: 1st - 16th month
Detect parameters during the WMs period which differentiate normalising and deteriorating GM traits by experts
Expert-guided clinical reasoning - "seeing through the eyes of an expert"
Time frame: 21st - 32rd month
Develop and provide expert-guided video recordings to complement GMA trainings with three modes of visual expert guidance (i: verbal; ii: visual; iii: verbal+visual) to enhance clinical reasoning in novice observers
Implementation of a database and intensive remote GMA training
Time frame: 17th - 48th month
Create the prototype of a password-protected database for clinical GMA training. The database will cover three distinct aspects of GMA training: (i) expert-guided remote training, (ii) re-calibration, and (iii) self-evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Reasoning and Cerebral Palsy, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spotlight on the very early motor repertoire: writhing general movements (WMs); GMA experts only (time frame: 1st - 16th month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.